(197 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
This document describes the acceptance criteria and performance of "Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile" as part of a 510(k) summary for FDA approval.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard / Acceptance Criteria | Device Performance (Current Device) |
|---|---|---|
| Dimensions | ASTM D6319-10 (Standard specifies requirements for dimensions) | MeetsLength min 230mmWidth min 95±10 |
| Physical Properties | ASTM D6319-10 (Standard specifies requirements for physical properties) | MeetsBefore AgingTensile Strength min 14 MPaUltimate Elongation Min 500%After AgingTensile Strength min 14 MPaUltimate Elongation Min 400% |
| Thickness | ASTM D6319-10 (Standard specifies requirements for thickness) | MeetsFinger min 0.05mmPalm min 0.05mm |
| Powder Free | ASTM D6124-06 (Standard specifies method for measuring powder) | Meets≤ 2 mg/glove |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Under the conditions of the study, not an irritant. |
| Dermal Sensitization - ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c) (4) | Under the conditions of the study, not a sensitizer. | |
| Watertight (1000ml) | ASTM D5151-06 (Standard for detecting leaks, specifically AQL 2.5) | PassesAQL 2.5 |
| Material | ASTM D6319-10 (Standard for Nitrile examination gloves) | Nitrile |
| Color | N/A (Comparison to predicate) | Blue |
| Texture | N/A (Comparison to predicate) | Finger textured |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use |
| Intended Use | The device is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for watertightness, tensile strength, etc.). However, it refers to compliance with ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10:2010(E). These standards typically specify the appropriate sampling plans and sample sizes required for testing.
The data provenance is Malaysia, as the submitter, WRP Rubber Products Sdn Bhd, is located in Sepang, Selangor Darul Ehsan, Malaysia. The data would be considered prospective in the sense that WRP Rubber Products Sdn Bhd conducted these tests for the purpose of their 510(k) submission, likely on batches of the device intended for market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. The provided document is for a medical device (examination gloves) that relies on engineering and biological performance standards, not diagnostic interpretative tasks. The "ground truth" is established by adherence to defined technical specifications and results from laboratory testing, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review processes, such as in clinical trials or image interpretation studies where discrepancies between initial assessments need to be resolved. For performance testing against objective standards, the results are typically quantitative and directly compared to the specified criteria without a need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This document concerns the regulatory approval of patient examination gloves, which are physical medical devices, not AI-powered diagnostic or assistive tools. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this document is for a physical medical device (examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by objective, standardized laboratory test results compared against predefined technical specifications and regulatory standards. For example:
- Dimensions: Measured values compared against minimum length and target width.
- Physical Properties (Tensile Strength, Elongation): Measured values compared against minimum performance criteria before and after aging.
- Powder Free: Measured amount of powder compared against a maximum limit (≤ 2 mg/glove).
- Watertight: Result of water leak test compared against the AQL 2.5 standard.
- Biocompatibility: In-vivo (likely animal) or in-vitro tests demonstrating lack of irritation or sensitization as per ISO 10993.
These are verifiable, quantitative, and qualitative outcomes from standardized test methods.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve AI or machine learning, thus no training set is relevant.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2014
WRP Rubber Products Sdn Bhd Mr. Lim Chin Yit Head of Operations Lot 3, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, Selangor Darul Ehsan MALAYSIA 43900
Re: K140418
Trade/Device Name: Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 10, 2014 Received: July 14, 2014
Dear Mr. Yit:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Yit
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K140418
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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1.0 Submitter:
| Name: | Mr. Lim Chin Yit |
|---|---|
| Address: | WRP Rubber Products Sdn BhdLot 3, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60166957817 |
Date of Summary Prepared: 18 August 2014
2.0 Name of the device:
Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Dermagrip-N Powder Free Blue Nitrile Examination Gloves 510(k) : K022904 MDL : D036500 Regulatory Class I Product Code : LZA
4.0 Description of The Device:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergo surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
5.0 Intended Use of the Device:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finqer to prevent contamination between patient and examiner.
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510(k) SUMMARY
Summary of the Technological Characteristics of the Device: 6.0
The Powder Free Blue Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Dimensions | ASTM D6319-10 | Meets | MeetsLength min 230mmWidth min 95±10 |
| Physical Properties | ASTM D6319-10 | Meets | MeetsBefore AgingTensile Strengthmin 14 MPaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MPaUltimate ElongationMin 400% |
| Thickness | ASTM D6319-10 | Meets | MeetsFinger min 0.05mmPalm min 0.05mm |
| Powder Free | ASTM D6124-06 | Meets≤ 2 mg/glove | Meets≤ 2 mg/glove |
| Biocompatibility | Primary SkinIrritation -ISO 10993-10:2010(E) &ConsumerProduct SafetyCommission,Tittle 16,Chapter II, Part1500 | Under theconditions ofthe study, notan irritant | Under the conditionsof the study, not anirritant. |
| DermalSensitization -ISO 10993-10:2010(E) &ConsumerProduct SafetyCommission,Tittle 16,Chapter II, Part1500.3(c)(4) | Under theconditions ofthe study, nota sensitizer. | Under the conditionsof the study, not asensitizer. | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| Predicate | Current | ||
| Watertight (1000ml) | ASTM D5151-06 | Passes | PassesAQL 2.5 |
| Intended use | - | The powderfree blueNitrileexaminationglove, non-sterile is adisposabledevice and ismade ofsyntheticrubberintended formedicalpurposes thatis worn on theexaminer'shand or fingerto preventcontaminationbetweenpatient andexaminer. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontamination betweenpatient and examiner. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue | Blue |
| Texture | - | Fingertextured | Finger textured |
| Size | Medical GloveGuidance Manual- Labeling | SmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large |
| Single Use | Medical GloveGuidance Manual- Labeling | Single use | Single use |
| Manufacturer(s) | - | WRP AsiaPacific SdnBhd | WRP Rubber ProductsSdn Bhd |
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510(k) SUMMARY
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for thickness. The current device is thinner than the predicate device, however it meets the ASTM standards.
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7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is as safe and as effective and substantially equivalent to the predicate device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.